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Purelift

FDA UDI

Class II (US FDA UDI)

by Xtreem Pulse, LLC

Identity

Trade Name
PURELIFT FDA UDI
Generic Name
Facial muscle cosmesis electrical stimulator FDA UDI
Device Name
The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres. FDA UDI
Model / Reference
PRO PLUS FDA UDI
Description
The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres. FDA UDI

Identifiers

Catalog Number
PURELIFT PRO PLUS FDA UDI
Primary DI / UDI-DI
00860008851031 FDA UDI
510(k) Number
K221443 FDA UDI
FDA Product Code
NFO FDA UDI
GMDN Term
Facial muscle cosmesis electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 20.7 Centimeter FDA UDI
Width — 4.8 Centimeter FDA UDI
Outer Diameter — 4.5 Centimeter FDA UDI

Category: Facial muscle cosmesis electrical stimulator

Purelift by Xtreem Pulse, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facial muscle cosmesis electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xtreem Pulse, LLC

Sources (1)

  • FDA UDI aa73e3e5-7077-496a-9747-857604488096 37 fields · synced Jun 6, 2026